Judicialization of access to medicines in four Latin American countries: a comparative qualitative analysis

Abstract

Background The valuation of medicines as health needs vary depending on the stakeholders involved (users, prescribers, managers, etc.) and their expectations. These factors modulate the role of medicines as a health need and influence access to medicines, and could be useful to explain the rising of Judicialization of access to medicines. Aim To conduct a comparative analysis of the causes and consequences of judicialization of access to medicines in Argentina, Brazil, Colombia and Chile from the perspective of medicines as health needs. Methods A qualitative, cross-country study was carried out in these 4 countries. Semi-structured interviews were conducted with 50 representatives of the different stakeholders involved in the judicialization of access to medicines, including Executive branch, Judiciary, health system managers, patient organizations. The interviews were audio-recorded and transcribed verbatim. Thematic analysis used a framework approach based on the theoretical model for medicines as health needs. Findings Representatives from Argentina, Brazil and Colombia considered judicialization of access to medicines as a widespread phenomenon in their respective countries. Meanwhile in Chile, the respondents highlighted that most lawsuits related to the right to health were filed against private insurers because of unjustified increases in the insurance premiums. The comparative analysis showed that judicialization of access to medicines emerged in the four countries regardless of the constitutional protection or the health system population coverage. Among the causes were mentioned difficulties in guaranteeing access to covered medicines and the influence of pharmaceutical marketing on needs assessment and prescription behaviours. The interviewees highlighted the pressure to health system managers to fulfil their responsibilities as a positive impact of litigation. In contrast, the funding of medicines without evidence of efficacy or safety was considered a negative impact. Only in Brazil, judicialization has had impact on R&D policies. In Colombia, litigation also encouraged the recognition of the right to health as a fundamental right and the development of policies for controlling medicines prices. Conclusion The results suggest that applying the adopted theoretical model creates the possibility of identifying critical points to guide policy makers to improve the health systems performances and to control lawsuits for access to medicines. Electronic supplementary material The online version of this article (10.1186/s12939-019-0960-z) contains supplementary material, which is available to authorized users.

Strategies Implemented by Public Institutions to Approach the Judicialization of Health Care in Brazil: A Systematic Scoping Review

“…This can compromise the health care and legal services provided for all users and can also serve to disrupt these institutions, both administratively and financially (Siqueira, 2015;Tribunal de Contas da União, 2017). Consequently, these institutions are required to reorganize and reallocate resources earmarked for other purposes in order to comply with court orders for health care technologies (Tribunal de Contas da União, 2017;Vargas-Pelaez et al, 2019).…”

“…Their results often bring an increase in the number of services that must be offered, health technology expenditures when health care needs could be more efficiently met using other products that existing in the public health care system, and significant costs associated with lawsuits. Furthermore, it can also lead to fines, seizing of funds, and even imprisonment of managers for noncompliance with court order (Vieira and Zucchi, 2007;Delduque et al, 2013;Tribunal de Contas da União, 2017;Vargas-Pelaez et al, 2019).…”

“…Public Administration driven by pressures to expand services and health care technologies, is being institutionally reorganized to meet these demands (Vargas-Pelaez et al, 2019). However, the strategies used to approach the judicialization in Brazil, in both the legal and health areas, have not yet been categorized as to their organization and operation.…”

“…The effect of increase in the number of lawsuits is alterations in the health care delivery that public institutions are able to provide to the public, in that these institutions now need to prioritize compliance with court orders to the detriment of systemic rationality in the provision of access to health care ( Chieffi and Barata, 2009 ; Tribunal de Contas da União, 2017 ; Vargas-Pelaez et al., 2019 ).…”

Pacientes com diabetes mellitus tipo 2 em uso de medicamentos via judicial

“…Motivada por questões econômicas, cientificas, legais e sociais, a judicialização visa a obtenção de produtos ou serviços de saúde que não estão disponíveis no sistema de saúde ou formas não convencionais de acesso. 7 Introducción: El aumento continuo en el número de procesos de judicialización de la salud, la relevancia epidemiológica de la diabetes mellitus tipo 2 (DM2), la escasez de recursos utilizados para monitorear las inversiones en procesos judiciales y de su alto costo para la salud pública, se vuelven necesarios estudios que analicen el perfil de la judicialización de los antidiabéticos, que es la principal clase de medicamentos a las que se dirigen los procesos judiciales. Objetivo: Analizar si los pacientes con DM2 atendidos vía judicial, fueron acompañados y monitoreados en el Sistema Único de Salud (SUS) antes y después de los procesos judiciales.…”